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Trial record 3 of 8497 for:    Lung Institute

Crossover Blinded Trial of Cell Therapy Versus Placebo in COPD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03228121
Recruitment Status : Withdrawn (Enrollment did not meet expectations)
First Posted : July 24, 2017
Last Update Posted : September 13, 2018
Sponsor:
Information provided by (Responsible Party):
Melissa Rubio, PhD, APRN, Lung Institute

Tracking Information
First Submitted Date  ICMJE July 20, 2017
First Posted Date  ICMJE July 24, 2017
Last Update Posted Date September 13, 2018
Actual Study Start Date  ICMJE April 24, 2017
Actual Primary Completion Date September 11, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 21, 2017)
Change in Quality of Life Score [ Time Frame: 3 months, 6 months following each treatment ]
Change in QOL score from baseline to 3 months and 6 months following each treatment
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 21, 2017)
Change in FEV1 [ Time Frame: 6 months following each treatment ]
Change in FEV1 from baseline to 6 months post-treatment
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Crossover Blinded Trial of Cell Therapy Versus Placebo in COPD
Official Title  ICMJE Crossover Blinded Trial of Cell Therapy Versus Placebo in COPD
Brief Summary The aim of this randomized, controlled crossover designed study is to compare the outcomes of receiving autologous, adult stem cells versus placebo among participants with chronic obstructive pulmonary disease (COPD). The study is limited to self-funded participants with a diagnosis of COPD. The study, along with others at the Lung Institute, have received full review and approval of an Institutional Review Board.
Detailed Description

The purpose of the Lung Institute is to collect, minimally process, and administer a person's own stem cells and/or platelet rich plasma and deliver the product back to the patient same-day through an intravenous catheter. This study is limited to patients diagnosed with chronic obstructive pulmonary disease (COPD) and is a double-blinded prospective, cohort trial using cross-over methodology. The aim of this study is to determine if stem cell therapy is better than placebo among a group of patients with COPD.

50 participants will be recruited for each arm of the study.

Cohort A will receive three days of cell therapy using the venous procedure (three consecutive days of blood harvest, cell separation and cell application). Cohort A will return in three months and receive three consecutive days of placebo.

Cohort B will receive three consecutive days of placebo. Cohort B will return in three months and receive three consecutive days of cell therapy using the venous procedure.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:

0 participants will be recruited for each arm of the study.

Cohort A will receive three days of cell therapy using the venous procedure (three consecutive days of blood harvest, cell separation and cell application). Cohort A will return in three months and receive three consecutive days of placebo.

Cohort B will receive three consecutive days of placebo. Cohort B will return in three months and receive three consecutive days of cell therapy using the venous procedure.

Masking: Double (Participant, Outcomes Assessor)
Masking Description:
Only the on-site PI and research nurse administering the treatment or placebo will know which group the participant belongs to. Patients are blinded. All follow-up contact and measurement of outcomes will be done by off-site research nurses who are blinded.
Primary Purpose: Treatment
Condition  ICMJE
  • COPD
  • Emphysema or COPD
  • Chronic Bronchitis
Intervention  ICMJE
  • Procedure: Treatment Then Placebo
    Cohort A will receive stem cells/PRP infusion during round one then placebo of normal saline infusion during round two.
  • Procedure: Placebo Then Treatment
    Cohort B will receive placebo of normal saline infusion during round one then stem cells/PRP infusion during round two.
Study Arms  ICMJE
  • Experimental: Cohort A
    Cohort A (Treatment Then Placebo group) will receive three days of cell therapy using the venous procedure (three consecutive days of blood harvest, cell separation and cell application). Cohort A will return in three months and receive three consecutive days of placebo.
    Intervention: Procedure: Treatment Then Placebo
  • Experimental: Cohort B
    Cohort B (Placebo Then Treatment group) will receive three consecutive days of placebo. Cohort B will return in three months and receive three consecutive days of cell therapy using the venous procedure.
    Intervention: Procedure: Placebo Then Treatment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: September 11, 2018)
0
Original Actual Enrollment  ICMJE
 (submitted: July 21, 2017)
100
Actual Study Completion Date  ICMJE September 11, 2018
Actual Primary Completion Date September 11, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients are included in treatment by self-referral and after consultation with a designated patient coordinator who determines initial eligibility, and then by the clinic nurse practitioner or physician of Lung Institute who determines final eligibility for inclusion. Patients must be diagnosed with chronic obstructive pulmonary disease (COPD) and be able to travel to the Dallas clinic location.

Exclusion Criteria:

  • Patients who are unable to provide informed consent, pregnant patients, prisoners, non-English speakers, patients with a history of cancer within the past 5 years, patients with active tuberculosis or pneumonia. Patients without a documented COPD diagnosis are excluded.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03228121
Other Study ID Numbers  ICMJE LI003
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Melissa Rubio, PhD, APRN, Lung Institute
Study Sponsor  ICMJE Lung Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Lung Institute
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP